01 November 2016

Think and Talk Together/ Pensar e Falar Junto

Exciting days in Rio with the extended drug product subteam 

The year of the Rio de Janeiro Olympics also sees some important milestones for the Pediatric Praziquantel CMC team. The manufacturing process for orally disintegrating levo-Praziquantel tablets (L-PZQ ODTs) is now being...

The team on the Farmanguinhos development and manufacturing site in Rio de Janeiro

Since 2014, ‘virtual’ collaboration has been familiar to the joint drug product sub-team from Consortium partners Farmanguinhos and Merck KGaA (Darmstadt, Germany) – due to the respective sites located more than 9500km apart. Team members always greatly value meeting face-to-face, so visiting fellows can acquire deeper insights into activities on the other side of the globe.

In March 2016, a visit to Rio by selected members from the Merck KGaA Darmstadt team, focused on preparing upcoming technology transfer of the manufacturing process from Merck KGaA (Darmstadt, Germany) to Farmanguinhos (Brazil). Such visits are usually intense and busy. Open and lively discussions continued all throughout the three-day stay.

Of particular interest was the joint elaboration of a detailed project plan. Due to the amount of tasks to consider (e.g. scale-up, integrated process and analytical transfer, supplies), a swarm of post-it stickers helped the teams to plan and review many different activities, and key milestones – gaining a common understanding of the way forward.

In June 2016, parts of the team reconvened in Darmstadt to talk through the transfer period. The agenda focused on strategy, exchanging on-site process knowledge, and sharing hands-on experience of the L-PZQ ODT manufacturing process with the Farmanguinhos colleagues.

A site visit to Brazil lies ahead in November 2016 – so-called ‘man-in-plant’ attendance. The Merck KGaA (Darmstadt, Germany) drug product expert and a co-worker will observe the manufacture of an industrial-scale batch of L-PZQ tablets at the GMP facilities in Rio. The “doors are always open” (“portas abertas” ) for Merck KGaA (Darmstadt, Germany) at Farmanguinhos, and vice versa.

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